Amiodarone HCl Injection

DRUG DESCRIPTION

Amiodarone HCl Injection contains amiodarone HCl (C25H29I2NO3•HCl), a class III antiarrhythmic drug. Amiodarone HCl is (2-butyl-3-benzofuranyl)[4-[2-(diethylamino)ethoxy]-3,5-diiodophenyl]methanone hydrochloride. Amiodarone HCl has the following structural formula:

Amiodarone HCI Structural Formula Illustration

Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. Amiodarone HCl injection is a sterile clear, pale-yellow micellar solution visually free from particulates. Each milliliter of the amiodarone HCl injection formulation contains 50 mg of amiodarone HCl, 20.2 mg of benzyl alcohol NF, 100 mg of polysorbate 80 NF, and Water for Injection USP.



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